A Liftless Intervention to Prevent Preterm Birth and Low Birthweight Among Pregnant Ghanaian Women: Protocol of a Stepped-Wedge Cluster Randomized Controlled Trial (Preprint)

Abstract

Background: Preterm birth (PTB) is a leading cause of infant morbidity and mortality in the world. Every year 20 million babies are born with low birthweight (LBW) and about 96% occurring in low-income countries. Despite their associated dangers, in about 40-50% of PTB and LBW cases, the causes are unexplained. Existing evidence is inconclusive as to whether occupational physical activities such as heavy lifting are implicated. African women bear the transport burden of accessing basic needs for their families. Ghana's preterm birth rate is 14.5% as compared to the global average of 9.6%. The proposed lift-less intervention aims to decrease lifting exposure during pregnancy among Ghanaian women. Our hypothesis is, a reduction in heavy lifting among pregnant women in Ghana will increase gestational age and birthweight.Method: A cohort stepped-wedge cluster randomized controlled trial in 10 antenatal clinics will be carried out in Ghana. A total of 1,000 participants will be recruited for 60 weeks period. To be eligible participant's pregnancy should be singleton between 12 to 16 weeks gestation, attending any of the 10 antenatal clinics and exposed to heavy lifting. All participants will receive standard antenatal care within the control phase and by random allocation; two clusters will transit into the intervention phase. The midwife-led 3-components lift-less intervention consists of health education, a take-home reminder card mimicking the colours of traffic light and a shopping voucher. The primary outcome will be gestational age at <28, 28-32 and 33-37 weeks. Secondary outcomes are LBW (preterm LBW, term but LBW and post term), compliance, prevalence of low back and pelvic pains and premature uterine contractions.Objective: To investigate the effects of the lift-less intervention on the incidence of prematurity and low birthweight among Ghanaian pregnant women. Results:The results of the trial will be published in a peer reviewed journal. It will increase knowledge in the prevention of PTB and low birth weight worldwide. Conclusion:To the best of our knowledge, there has been no randomized trial of this nature in Ghana. Minimizing heavy lifting among African pregnant women can reduce the soaring numbers of preterm and LBW.